HARDY DIAGNOSTIC McFarland Standard 0.5; in vitro diagnostic, glass vial, one vial per box
FDA device recall Z-0669-2009 · posted 2009-01-28 · Terminated
Recall details
- Recalling firm
- Trek Diagnostic Systems
- Reason for recall
- Incorrect result: The absorbance has changed as the standards have aged; the standards' turbidity has become denser. The recalled lot is now reading 0.15 ABS @ 625 nm. TREK'S internal specification and the manufacturer's (Hardy Diagnostics) specification is 0.08 - 0.10 ABS @625 nm. CLSI specifies 0.08 - 0.13 ABS @ 625 nm.
- Action taken
- On 9/22/2008 TREK Diagnostic sent a recall notification letter to their customers advising them of the problem with the product. They instructed their customers to inventory their stock for any remaining recall lot and immediately destroy.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JTZ
- Quantity affected
- 4 vials
- Distribution
- USA distribution in OH and IL.
- Date initiated
- 2008-09-22
- Date posted
- 2009-01-28
- Date terminated
- 2010-07-06
- Location
- Cleveland, OH
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